ARDSEITICUNCT07184580
Electrical Impendance Tomography Usage in ICU
An observational study of ARDS and Alveolar Recruitment Manoeuvres, run by Erasme University Hospital.
Trial summary
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1). It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- ARDS, Alveolar Recruitment Manoeuvres, Prone Position
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to Apr 2031
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All critical care patients for whom clinicians estimated the need for EIT measurements could be included, except pediatric patients under 12 years of age, as the belt used for this device is not designed for children.
Who may be able to join
- Patient aged more than 12 years old (no pediatric EIT belt)
- Patient monitored by an EIT belt
- Exclusion criteria Patient who expressed opposition to participate.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electrical Impendance Tomography Usage in ICU : Registry Creation
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1).
It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4).
Read more
Despite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8).
Recently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary "pulsatility," thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10).
In this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies.
Standard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed.
This registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring.
Data will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient.
Data collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems.
There are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings.
Patients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay.
As this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year.
Inclusion Criteria for ICU Patients:
- Patient aged more than 12 years old (no pediatric EIT belt)
- Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.
- Conditions
- ARDS, Alveolar Recruitment Manoeuvres, Prone Position, Electrical Impedance Tomography (EIT)
- Keywords
- ARDS, Recruitment manoeuvres, Prone positioning, PEEP optimization, EIT, Electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patients | Mechanically ventilated patients for which an EIT belt has been placed, for PEEP optimization, ventilation monitoring, prone positioning evaluation,... | |
| Non-invasive ventilation patients | Patients included in the study who are only on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Assessment of mortality
Measured: up to 30 days
Secondary outcomes (4)
PaO2/FiO2 ratio
Measurement on PaO2/FiO2 before and after the usage of EIT
Measured: During the measurement using the EIT in the ICU
Hospital mortality rate
Hospital mortality
Measured: Through hospital discharge (average of 14 days)
Ventilation free days
Number of days without ventilation for patients who are mechanically ventilated
Measured: 28 days since the start of ventilation
Mechanical power
Measurement on mechanical power before and after the usage of EIT
Measured: During the measurement using the EIT in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Dehout, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184580
- Sponsor's protocol ID
- HUB2025218
- Acronym
- EITICU
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.
PubMed 34193224Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.
PubMed 38512400Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.
PubMed 36650593Kim Y, Webster JG, Tompkins WJ. Electrical impedance imaging of the thorax. J Microw Power. 1983 Sep;18(3):245-57. doi: 10.1080/16070658.1983.11689329.
PubMed 6558130
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impendance Tomography Usage in ICU : Registry Creation
- ClinicalTrials.gov ID
- NCT07184580
- Acronym / sponsor ID
- EITICU / HUB2025218
- Conditions
- ARDS, Alveolar Recruitment Manoeuvres, Prone Position, Electrical Impedance Tomography (EIT)
- Keywords
- ARDS, Recruitment manoeuvres, Prone positioning, PEEP optimization, EIT, Electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1).
It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4).
Despite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8).
Recently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary "pulsatility," thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10).
In this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies.
Standard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed.
This registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring.
Data will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient.
Data collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems.
There are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings.
Patients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay.
As this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year.
Inclusion Criteria for ICU Patients:
- Patient aged more than 12 years old (no pediatric EIT belt)
- Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | –Mechanically ventilated patients for which an EIT belt has been placed, for PEEP optimization, ventilation monitoring, prone positioning evaluation,... |
| Non-invasive ventilation patients | – | –Patients included in the study who are only on |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All critical care patients for whom clinicians estimated the need for EIT measurements could be included, except pediatric patients under 12 years of age, as the belt used for this device is not designed for children.
Key inclusion criteria (3 listed)
- Patient aged more than 12 years old (no pediatric EIT belt)
- Patient monitored by an EIT belt
- Exclusion criteria Patient who expressed opposition to participate.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality rate
Time frame: up to 30 days
Assessment of mortality
4 secondary outcomes
PaO2/FiO2 ratio
Time frame: During the measurement using the EIT in the ICU
Hospital mortality rate
Time frame: Through hospital discharge (average of 14 days)
Ventilation free days
Time frame: 28 days since the start of ventilation
Mechanical power
Time frame: During the measurement using the EIT in the ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 30776290Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Background: PubMed 34193224He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.
- Background: PubMed 38512400Songsangvorn N, Xu Y, Lu C, Rotstein O, Brochard L, Slutsky AS, Burns KEA, Zhang H. Electrical impedance tomography-guided positive end-expiratory pressure titration in ARDS: a systematic review and meta-analysis. Intensive Care Med. 2024 May;50(5):617-631. doi: 10.1007/s00134-024-07362-2. Epub 2024 Mar 21.
- Background: PubMed 36650593Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.
- Background: PubMed 6558130Kim Y, Webster JG, Tompkins WJ. Electrical impedance imaging of the thorax. J Microw Power. 1983 Sep;18(3):245-57. doi: 10.1080/16070658.1983.11689329.
- Individual participant dataSharing planned: Undecided
Related trials for ARDS
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Alveolar Recruitment Manoeuvres, run by Erasme University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Dehout, M.D (+ 32 2 555 6589, charles.dehout@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184580, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.